Join Us for the Fourth Annual Bio Supply Chain Academy Conference
November 7-8, 2011

"Reducing Healthcare Costs and Maximizing Quality Patient Care through Worldwide Supply Chain Partnering, Innovation and Entrepreneurship in the Bio Life Sciences Industry"

SECOND ANNUAL
BIOTECH SUPPLY CHAIN ACADEMY

Rx FOR A LEAN & HEALTHY BIOTECH SUPPLY CHAIN
COLLABORATING FOR PROGRESS

 OCTOBER 19-20, 2009

SOUTH SAN FRANCISCO CONFERENCE CENTER
255 South Airport Boulevard
South San Francisco, California 94080

Biotech Supply Chain Academy 2009 CONFERENCE PROGRAM

(Click on the Session Title for a copy of the presentation)

MONDAY, OCTOBER 19
8:00
Registration and Continental Breakfast
8:30

Welcome Address:  Devendra Mishra, Executive Director, Bio Supply Management Alliance
8:40
 
PPT
Keynote Address

"Regulatory Influences in Biogenerics: The Next Horizon"

Recognized as one of the world's leading expert on follow-on protein products and follow on biologics ("biosimilars" in the European Union), Dr. Woollett will address an array of scientific and science policy issues in connection with legislative, regulatory, public affairs, and communications initiatives involving the government, industry, the research community, in the biologics and biotechnology areas in the USA and Europe. The presentation will also focus on the effectiveness of collaboration of biopharma companies' with regulatory agencies in multiple aspects of discovery, development, and manufacture of biotechnology-based medicines.

Speaker: Dr. Gillian R. Woollett, Chief Scientist, Engel & Novitt, LLP
9:20
 
PDF
Keynote Address

"Why Collaborate in the Biotech Industry"

Until recently, as long as the average biotech company?s pipeline was productive, the warehouse was full and the underlying cost structure was manageable; these companies realized very healthy profit margins and sustained top-line growth.  So what happened to cause so many biotech companies to reconsider their supply chain strategy?  Global competition to reach emerging markets, increased pressure on pricing and reimbursement, under-utilized capacity of large manufacturing facilities and expensive stocks of inventory are all calling the biotech supply chain executive to action.  Operational excellence in supply chain and collaboration across the value chain, every biotech executive?s keys to unlocking sustainable value, will be discussed.  Furthermore, a preview of AMR Research?s development of their first annual Healthcare Top 25 ranking will be presented.

Speaker: Wayne McDonnell, Research Director, Health & Life Sciences, AMR Research
9:50
NETWORKING BREAK
10:10
Operations Executives Panel

"Managing the Enterprise in Turbulent Times"

Executives of biotech companies will discuss the biggest challenges they have already conquered, are addressing now, and will potentially face. The opportunities, impediments and risks from end-to-end are multi-faceted, such as commercialization of innovations, clinical trials global outsourcing, lean and contract manufacturing, information sharing, visibility and asset management in the supply chain. The panelists will also answer questions - How has the economy changed sourcing and delivery? What will their supply chain look like in five years?  This important session provides a forum for an informative Q&A about collaboration along the entire supply chain.

Panelists:

Alison Moore
, VP, Corporate Manufacturing, Amgen
Andrew Ramelmeier
, VP, Manufacturing and Process Development, BioMarin Pharmaceutical
Dave Malenfant
, VP, Global Supply Chain, Alcon Laboratories
Franklyn Hathaway
, Director, Supply Chain Excellence, Bayer Healthcare
Mark Buck
, Global Supply Chain and Procurement Leader, Bio-Rad Laboratories

Moderator: Devendra Mishra, Adjunct Professor, Graziadio School of Business & Management
10:50
 
PDF

"Rx 360: Global QA for Suppliers"

A non-profit consortium from the pharmaceutical industrial complex has been established to develop operating standards, share data and create an independent supplier audit function to improve the efficiency, oversight and accountability of the bio-pharmaceutical supply chain. The Deming-based approach promises the benefits of cost reduction in the supply chain, standardization of best practices, monitoring of quality and security, and establishment of world-class suppliers will be analyzed. In addition, the necessary interface with the Government will be highlighted.

Speaker: Eric L. Berg, Director, Supplier Quality, Amgen
11:20
 
PDF
Panel

"Launch and Commercial Management: Overcoming the Achilles' Heel"

The commercialization of new products faces significant obstacles in terms of organizational structure, cross-functional collaboration for launch, transfer of knowledge, capacity planning under uncertainty, process control and optimization, and interface with distribution and the market place.

Panelists:
Shankar Suryanarayanan
, Co-Chairman, Biotech Supply Chain Academy;
Fred Gvillo
, Entrepreneur Biotechnology;
Lee Schruben
, Professor, University of California, Industrial Engineering and Operations Research, Berkeley

Moderator: Wayne McDonnell, Research Director, Health & Life Sciences, AMR Research
  12:00  LUNCH
SUPPLY CHAIN RISK MANAGEMENT TRACK
Laura Langone, JD, Former Director of Risk Management, Genentech
Chair, BSMA Risk Management Steering Committee

1:00
Keynote Address

"The 5 Risk Management Mistakes"

Projects are hard enough to manage without making the same mistakes others make.  How much would it be worth to you to learn the biggest mistakes others make related to project risk?  Join this humorous and informative workshop and take home pointers you can use right away.  Participants will learn the top 5 mistakes people make when it comes to Risk Management; understand why these mistakes are being made and better understand the risk management process as it is used in the real world.

Speaker: Rita Mulcahy, PMP, President, RMC Project Management
1:40

Panel:

"Supply Chain Risk Management: Safeguarding The Enterprise and Making It Resilient"

The strategic, financial, operational and hazard risks in the industry supply chain, from end to end, will be analyzed and current practices will be discussed with emphasis on information, systems, procedures and collaboration to achieve security, quality assurance.

Panelists:


Phil Kaminsky, UC Berkeley, Industrial Engineering and Operations Research
Dave Malenfant, SVP, Global Supply Chain and Head of Risk Management Committee, Alcon Laboratories
Michael Mitchell, Director, Global Supply Chain Management, SAFC Bioscience
Mohinder Sikka, CEO, Sensitel

Moderator: William Coakley,
Senior Director, Supply Chain Management, SciClone Pharmaceutical
2:20
 
PDF
"Supply Chain Risk Management: A Supplier Perspective"

One supplier's development in supporting biopharma industry response to China origin concerns and the broader implications for risk management collaboration. By including the supplier, the relationship can discern risks specific to the biopharma raw material supply chain.

Speaker: Michael Mitchell,
Director, Global Supply Chain Management, SAFC Bioscience
2:50

NETWORKING BREAK
SUPPLY CHAIN TALENT MANAGEMENT TRACK
Dave Malenfant, Vice-President, Global Supply Chain, Alcon Laboratories
Chair, BSMA Talent Management Steering Committee
3:10

 

PDF

"Development of Supply Chain Management Talent: The Intel Story!"

Starting in the 1980's, Intel - The world's largest manufacturer of micro-electronic parts, discovered that to compete, having the best technology was no longer good enough. It was required to build products at the right cost and the right volume, and then deliver them to customers at the right time.  Intel embarked upon the development of supply chain expertise in its ranks by setting up a special career track.  The results have fulfilled the strategic objective of Intel.  Its program later inspired CSCMP's Supply Chain Management Professional designation.  Intel also has the largest number of APICS CSCP professionals.

Speaker: K C Quah, CSCP, Supply Chain Master, Intel Corporation
3:40
 
PDF
"Developing Talent Beyond the APICS Supply Chain Manager Competency Model"

APICS developed the Supply Chain Manager Competency Model to guide individuals considering careers in supply chain management, supply chain professionals seeking to advance their positions, and human resource managers who are hiring in this fast-growing field.  In addition to discussing the competency model, this session will also identify how to extend supply chain manager capabilities beyond the APICS competency model to organizational vision and leadership; to alignment of supply chain initiatives to enterprise objectives; and to driving global strategy and relationships.

Speakers:


Tim Salaver, President, APICS Golden Gate Chapter and Executive Vice-President, Bio Supply Management Alliance
Andre Alves, Sr. Supply Chain Analyst, VSP Vision Care; Member, Future Leaders of APICS The Association for Operations Management;
4:10

Panel

"Supply Chain Talent Management - A Biotech Industry Prerogative!"

Proven solutions will be presented by leaders of the biotech and semi-conductor industry in conjunction with academia for the development of supply chain management professionals for all rungs of the ladder in a biotech enterprise. Development programs range from tactical to strategic management training of professionals.

Panelists:


Laura Meade, Associate Professor, Texas Christian University
Phil Kaminsky, Associate Professor, University of California, Berkeley
Nabil Rageh, Director, DBA Program, Golden Gate University
Adam Zak, Founder and CEO, Adam Zak Executive Search

Moderator: K C Quah, CSCP, Supply Chain Master, Intel
4:50
 
PDF
 

"Alcon Laboratories Partnership with Texas Christian University: A Model of Talent Development"

For over eight years Alcon and TCU have partnered to develop supply chain talent by mentoring students and projects which has resulted in over 100 projects with positive results.  Several students have been placed at Alcon after successful projects.

Speaker:

Dave Malenfant, Vice President, Global Supply Chain, Alcon Laboratories
Laura Meade, Associate Professor, Texas Christian University
5:15

COCKTAIL RECEPTION
TUESDAY, OCTOBER 20
8:00
Registration and Continental Breakfast
8:30

Panel:

"Distribution & Fulfillment: Ensuring Agility, Adaptability and Alignment"

Discussion to enhance the value added services between the manufacturer of the drug and the hospitals, doctors and patients. Solutions and best practices will be addressed, such as, collaborative planning, IT linkage, data synchronization, warehousing, transportation, fulfillment services, sustainability of the environment, etc.

Panelists:


Ronald Bone, Senior Vice President, Distribution Support, McKesson
Laurel Junk, Vice President, Procurement and Supply Chain, Kaiser Permanente
Jim Burleigh, CEO, SmartTurn
Dave Zaleski, Industry Manager, Dematic

Moderator: Robert Bowman, Senior Editor, SupplyChainBrain.com
9:20

Keynote Address

"The Building Blocks of a World-Class Distributor"


Distribution in the biopharma industry has expanded its services with extraordinary results. The information-driven service provider will highlight how customer-centricity can be achieved while reducing costs, decreasing lead times, and improving asset utilization.

Speaker: John Figueroa, President, McKesson U.S. Pharmaceutical
10:00
NETWORKING BREAK
10:20

 

PDF


"Enabling Visibility and Effective Collaboration Across the End-to-End Demand-Supply Network"

This presentation will discuss the strategic importance for life sciences companies to achieve visibility and collaboration with upstream and downstream trading partners. Participants will learn how they can leverage best practices from supply chain leaders in the high-tech industry to achieve better alignment between customer demand and supply, thereby improve revenue and shareholder value, while reducing inventory and operating cost.

Speaker: Richard McCluney
, General Manager, International Business, E2Open
10:50

 

PDF


"Elements of Supply Chain Visibility for Life Sciences"

Everyone talks about and wants supply chain visibility, but few even agree what it is.  This session applies research to answer several key questions:


 

  • What is supply chain visibility and what are its elements?
  • Why is it more important than ever? (Changing business models, increasing supply chain risk, effective supply chain management)
  • What are the challenges to achieving supply chain visibility and how can they be overcome?

 

Elements of visibility that will be touched on include chain-of-custody, RFID, cold chain/condition monitoring, supplier integration and visibility, supplier performance monitoring, supplier & supply risk monitoring, anti-counterfeiting/gray market, market/commodity monitoring/analysis, and sell-side (downstream) visibility

Speaker: Bill McBeath, Chief Research Officer, ChainLink Research

11:20

Panel

"Visibility in The Supply Chain: Building The Holy Grail"

Address the issues of achieving visibility in the supply chain from end-to-end, utilizing ePedigree and the current Government legislation, technology solutions, legal framework and best practices. A framework for Track-and-Trace being adopted by the food industry consisting of a technology-based infrastructure and software will also be discussed. 

Panelists:


Angela Watson, Corporate Vice President, Strategic Accounts, Healthcare Sector, UPS
Dina Bunn, Director, Customer Service and IT, LifeConEx
Laurel Junk, VP, Procurement and Supply Chain, Kaiser Permanente
Colin Finn, VP, Sales and Co-Founder, Pelyco Systems

Moderator:
Tom Magill, Executive Consultant, Judgment Index
12:00
LUNCH
12:15
Keynote Address

"SUPPLIER PERFORMANCE AND METRICS"

A case study on how Bio-Rad Laboratories measures the performance of their suppliers.

Speaker: Mark Buck
1:45
SALON E
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PDF4

 

SALON F

PDF

 


Panel (SALON E)

"4Ts of Cold Chain - Technology, Panel Tracking, Temperature-Controlled Transportation"

An innovator in Cold Chain, an RFID provider with hosted offerings, industry standards organization and a leading BioPharma company will address how to move the industry to more consistent, better understood and ultimately lower cost temperature assurance transport solutions. Solutions will be presented and discussed for expanded deployment of the technology from the clinical and bulk arenas to the commercial environment. The transfer of knowledge on scalable platforms is a large piece of the puzzle when looking to reduce total cost of ownership.

Panelists:

Ed Church, Executive Director, International Safe Transit Association
Frank Newman, Managing Director, Enterprise & Regional Account Management, FedEx
Garry Hutchinson, Director, Global Transportation, Amgen

Jim Cox, CEO, Temp Trip

Moderator: Rodney Derifield, President and Founder, EnviroCooler

Panel (SALON F)

"Building Effective Clinical Trials Supply Chains through Demand and Operations Planning"


The ability to map clinical trial demand streams, understand demand variability, and developing segmented clinical trial supply responses would yield significant benefits for life sciences companies. In this session clinical supply chain demand forecasting will be examined within the broader clinical trial resource alignment and a new, highly accurate demand forecasting platform.  This session will also introduce Demand Rationalization & Operations Planning (DR&OP) adopted from the traditional S&OP process and how to use DR&OP within your clinical trial to balance demand and supply to achieve peak performance.

Panelists:

Andrew Ramelmeier, VP, Manufacturing and Process Development, BioMarin Pharmaceuticals
Randy Schwemmin, Senior Manager, Clinical Supply Chain, Genentech 
Arun Cavale, CEO, Nexinfo
Laura Langone, former Director, Risk Management, Genentech

Moderator
: Wayne McDonnell, Research Director, Health & Life Sciences, AMR Research
2:30

 SALON E

PDF

 

 

 

 


"Profiting From Lean Six Sigma in Biotech: Experiences of The Best" (SALON E)

A Case Study of the successful evolution of lean six sigma principles from the automotive to discrete manufacturing to biotech will be analyzed to demonstrate contribution to the bottom line and customer satisfaction.

Speaker: Edgar Sur,
Head of Operational Excellence, Bayer Healthcare
"Supplier Collaboration for Sales and Operations Planning" (SALON F)

This session will define a solution that help companies implement a collaboration process to maximize the effectiveness of their S&OP process. The session will lay out the S&OP Process and it?s informational needs from suppliers. It will highlight some of the facets of the process that make it complex like demand striping and other demand level information like partial fulfillment; distinguishing existing contractual commitments; establishing other product level information like 'lot expiry', 'minimum shelf life', 'required product grade'; identifying cost impacts of changes to supply during iterative simulations; and visibility to safety stock and demand variability.

Speaker: Arun Cavale,
CEO, Nexinfo
3:05
Panel (SALON E)

"Developing Flexible Manufacturing Capabilities"

The panel will identify proven approaches for producing multiple products in a flexible manufacturing environment.  The challenges to be addressed - segregation, quick changeover, inventory management, disparate cells or product types, operator costs and ease of technology transfer.  

The pros and cons of building in a single site versus diversifying to multiple sites will be analyzed.  Key considerations include business continuity risks, availability of diverse expertise and capabilities, such as bulk production versus fill finish activities and business incentives.

Panelists:


Andrew Ramelmeier, Vice-President, Manufacturing & Process Development, BioMarin Pharmaceuticals
Robert Bottome, Head of Operational Excellence, Genentech
Rick Johnston, Director, Bioproduction Group, UC Berkeley
Dave Zaleski, Industry Manager, Dematic

Moderator:
Tim Salaver, EVP, Operations and Technology, Bio Supply Management Alliance
Panel (SALON F)

"Leveraging Partner Networks to Meet Supply Chain Challenges of Biotech Companies"


Increasing globalization and complexity in today?s biotech development and commercial supply chains creates opportunities for CROs and CMOs to partner with their biotech clients. Effective partnerships create significant value by providing supplemental competencies and capacity to accelerate time to market and maintain commercial supplies. Hear industry thought leaders discuss the strategic and tactical secrets to successful partnering.

Panelists:


Alison Moore,  VP, Corporate Manufacturing Amgen
Gustavo Mahler, President, C/M/C ICOS Biologics
Shabbir Anik,
President and CEO, Althea Technologies
Shankar Suryanarayanan
, Co-Chairman, Biotech Supply Chain Academy

Moderator:  Jay Vora Ph.D, Principal PRTM
3:50

CLOSING REMARKS: Devendra Mishra, Executive Director, Bio Supply Management Alliance (SALON E)


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